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An Online Wellness Intervention for University Students

Not Applicable
Completed
Conditions
Mental Health Wellness 1
Interventions
Other: COMET-GB
Registration Number
NCT05718141
Lead Sponsor
University of Bath
Brief Summary

The investigators want to understand the impact of a short online single session programme to improve well-being. Therefore, the investigators are investigating a self-help mental health intervention composed of four distinct modules, all designed to be completed within a single, 60-minute online session.Any university student in the UK can take part. Participants are randomly allocated to either:

1. Complete the COMET programme (lasting about 60 minutes) and to practice the skills learned over the next few weeks. Participants are asked to fill out online questionnaires (10-15 minutes) at two points in the future: two weeks from baseline, and four weeks from baseline.

Or

2. Complete a few extra online questionnaires (lasting about 20-30 minutes), and fill out brief questionnaires (10-15 minutes) two weeks and four weeks later. After filling out the questionnaires in four weeks time, participants will then have the opportunity to complete the COMET programme (lasting about 60 minutes).

Detailed Description

The study will use a randomised controlled trial (RCT) design, with a waiting list control (treatment as usual) group who will have the opportunity to access the intervention 4 weeks after randomisation. The intervention is digital and delivered online via Qualtrics. Participants will answer questions before completing the intervention, and at 2-week and 4-week follow-up. The single session intervention is expected to take \< 1 hour to complete, with the research study components taking \<20 minutes to complete.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
346
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention: COMET-GBCOMET-GBOnline single session intervention via qualtrics (any internet connected device) based on cognitive and behavioural principles.
Primary Outcome Measures
NameTimeMethod
Well-being4 weeks post randomisation

Warwick-Edinburgh Mental Well-being Scale (WEMWBS) - has 14 items that captures participants feelings and thoughts that best describe their experience over the previous 2 weeks using a scale from 1 to 5. Higher scores indicate better wellbeing.

Secondary Outcome Measures
NameTimeMethod
Depressive symptoms2 weeks, 4 weeks post randomisation

Patient Health Questionnaire-9 (PHQ-9), a commonly used measure for depressive symptoms. The PHQ-9 has 9 items which capture the frequency of depressive symptoms over the preceding two weeks using a scale from 0-3. A score of 0-4 indicates no depression, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15- 19 indicates moderately severe depression and 20-24 indicates severe depression. The PHQ-9 has a sensitivity and specificity of 88% for detecting clinical depression.

Anxiety symptoms2 weeks, 4 weeks post randomisation

General Anxiety Disorder 7-item Checklist (GAD-7), a commonly used measure for symptoms of anxiety. The GAD-7 has 7 items which capture the frequency of anxious symptoms over the preceding two weeks using a scale from 0-3. A score of 0-4 indicates no anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety and ≥15 indicates severe anxiety. The GAD-7 has a sensitivity and specificity of 89% and 82% respectively.

Positive and negative affect2 weeks, 4 weeks post randomisation

Positive and Negative Affect Schedule (PANAS), a commonly used measure of positive and negative affect. The PANAS has 20 items that captures participants feelings of positive and negative affect over the past week using a scale from 1 to 5.

Well-being2 weeks post randomisation

Warwick-Edinburgh Mental Well-being Scale (WEMWBS), a commonly used measure of well-being. The WEMWBS has 14 items that captures participants feelings and thoughts that best describe their experience over the previous 2 weeks using a scale from 1 to 5. Higher scores indicate better wellbeing.

Trial Locations

Locations (1)

University of Bath

🇬🇧

Bath, Banes, United Kingdom

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